16.1 Purpose
The purpose of this SOP is to provide procedures to select a study site and how it is to be monitored for its performance or compliance with GCP.
16.2 Scope
This SOP applies to any visit and /or monitoring of any study sites of IRB-approved study protocols.
16.3 Responsibility
It is the responsibility of the IRB members to perform or designate some qualified agents to perform on its behalf on-site inspection of selected study sites of relevant projects it has approved. The IRB members or Secretariat in consultation with the chairperson may initiate an on-site evaluation of a study site for cause or for a routine audit.
16.4 Detailed instructions
16.4.1 Selection of study sites
- Sites will be identified for routine monitoring at the time of approval of the project by the Full Board which will be recorded in the minutes
- Select study sites needed to be monitored based on the following criteria:
For cause – site for a reason
- The high number of protocol violations/ deviations
- A large number of proposals carried out at the study site or by the same researcher
- A large number of SAE reports
- High recruitment rate
- Complains received from participants
- Any adverse media report
- Adverse information received from any other source
- Non-compliance with Ethics committee directions
- Misconduct by the researcher
16.4.2 Before the visit
- If the site was identified for routine monitoring, the secretariat will inform the IRB members in the Full Board meeting, 1 month prior to the stipulated date of
- For causes / routine monitoring of the project, The IRB Secretariat only will:
- Contact the site to notify them that they/ their representative will be visiting them.
- Inform the PI in writing about the date/time of the monitoring visit and request a confirmation letter from the PI to be available for the monitoring visit.
- Make the appropriate travel arrangements.
- Review the IRB project files for the study and site profile and make appropriate
- Copy some parts of the IRB project files for comparison with the site files.
16.4.3 During the visit:
- Get the monitoring visit report.
- Review the informed consent document to make sure that the site is using the most recent version,
- Review randomly the subject files to ensure that subjects are signing the correct informed consent,
- Observe the informed consent process, if possible,
- Observe the laboratory and other facilities necessary for the study at the site, if possible.
- Review the project files of the study to ensure that documentation is done appropriately, records are accurate, complete, kept up-to-date and
- Ensure that the investigator and the investigator’s trial staff are adequately informed about the trial functions and functioning in accordance with the protocol and any other written agreement between the sponsor and the investigator/institution, and have not delegated these functions to unauthorized indiv
- Determine whether all adverse events (AEs) are appropriately reported within the time periods required by GCP, the protocol, the IRB, the sponsor, and the applicable regulatory requirement(s).
- Collect the views of the study participants, if
- Get immediate feedback.
16.4.4 After the visit
• The IRB representative will,
- Complete the report describing the findings of the monitoring visit and during the Full IRB meeting present them. If the IRB representative is unable to attend the IRB meeting he/she can courier the Monitoring Visit Report with comments and the IRB secretary can present, the same.
• The Secretariat will,
- The Secretariat will place the report in the correct
- IRB meeting recommendations to change the study / premature termination /continuation of the project will go to the PI in writing.